Development and Usability Testing of a Progressive WebApp for Women With Heart Disease

NCT03800082 | Unknown

• 1 other identifier: 389044
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this program of research is to develop and systematically evaluate an integrated smartphone and web-based intervention (at heart \[formerly called HEARTPA♀N\]) to provide evidence-informed symptom triage and self-management support to reduce pain and increase health-related quality of life (HRQoL) in women with heart disease. The investigators will use the individual and family self-management theory, mobile device functionality and the pervasive information architecture of mHealth interventions, and follow the sequential phased approach recommended by the Medical Research Council (MRC) to develop at heart (progressive WebApp). Funding was received from the Canadian Institutes of Health Research to develop the architecture and conduct usability testing (Phase 2, complete) to ensure it is easy to use, efficient and satisfying to operate. In Phase 3 (current proposal), feasibility in terms of implementation (accrual rates, acceptability and level of engagement) and initial estimation of effectiveness outcomes (estimates of magnitude of effect) will be evaluated in a pilot randomized controlled trial (RCT). The Phase 3 pilot study will enable the investigators to refine the prototype, inform the methodology, and calculate the sample size for a larger multi-site RCT (Phase 4, future work).

Conditions

Pain; Cardiac Ischemia; Women; Pain, Chronic

Keywords

Women, Self-Management, Cardiac Pain

Outcome Measures

Primary Outcomes (2)

• Feasibility (recruitment, retention, engagement)

  A process evaluation will be used to assess the feasibility of the implementation of the intervention. The PC will track any issues or difficulties encountered during trial implementation, such as problems using the app. Engagement will be assessed using Google Analytics, which will track patterns of app and website usage. Engagement with the app diary will be defined as 100% with daily entries for 3 months. Engagement with goal setting will be defined as 100% when 12 goals are identified over the 3-month period. Criteria for implementation success: recruitment rates \> 70%, retention \> 85%, minimal technical difficulties reported by \< 10%, engagement \> 80%, and minimal missed responses. Prevalence of refusal, retention, engagement and technical difficulties reported will be calculated with their 95% confidence intervals.

  3 months

• Feasibility (acceptability, satisfaction)

  The investigators will also assess acceptability and satisfaction in all participants in the intervention group using a modified Acceptability e-Scale (AES). The modified AES includes 9 items, each with a 5-point Likert response. Higher scores represent better acceptability/satisfaction. Responses are summed and averaged. Criteria for implementation success: AES mean summary score \> 4.

  3 months

Secondary Outcomes (2)

• Pain (Brief Pain Inventory)

  3 months

• Health-related quality of life (HRQOL)

  3 months

Study Arms (2)

Control

NO INTERVENTION

Participants allocated to the control group will receive the usual care and supports provided to women with cardiac pain, including usual clinic appointments and follow-up.

Treatment

EXPERIMENTAL

Participants allocated to the treatment group will also learn how to use the progressive WebApp intervention. The intervention will be delivered on restricted password-protected applications that will permit tracking of adherence (number of logins to app and website using Google Analytics). Participants will be encouraged to log-in regularly to the progressive WebApp (via automated alerts) over the 3-month period to complete a Heart and/or Wellness Check. A Chatbot named 'Holly' will assist women with log-in and maintaining health and wellness. Participants will be directed to the PC for technical problems.

Behavioral: at heart (changed from HEARTPA♀N during usability testing)

Interventions

at heart (changed from HEARTPA♀N during usability testing) BEHAVIORAL

An integrated smartphone and web-based intervention (at heart) to provide evidence-informed symptom triage and self-management support to reduce pain and increase health-related quality of life (HRQoL) in women with heart disease. The intervention for participants randomized to the treatment group will consist of regular use of a progressive WebApp that is managed by a Chatbot named 'Holly', in addition to usual care, for a period of 3 months.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: We will use the PRAXY Gender Questionnaire - Short Form
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women greater than 18 years of age with obstructive and non-obstructive CAD pain, post PCI/cardiac surgery pain lasting greater than 3 months
• women will be required to speak and read English

You may not qualify if:

• severe cognitive impairment assessed using the Six-Item Screener
• major co-morbid medical or psychiatric illness that could preclude their ability to participate

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Monica Parry

Toronto, Ontario, M5T 1P8, Canada

RECRUITING

Related Publications (1)

• Parry M, Dhukai A, Clarke H, Bjornnes AK, Cafazzo JA, Cooper L, Harvey P, Katz J, Lalloo C, Leegaard M, Legare F, Lovas M, McFetridge-Durdle J, McGillion M, Norris C, Parente L, Patterson R, Pilote L, Pink L, Price J, Stinson J, Uddin A, Victor JC, Watt-Watson J, Auld C, Faubert C, Park D, Park M, Rickard B, DeBonis VS. Development and usability testing of HEARTPAfemale symbolN: protocol for a mixed methods strategy to develop an integrated smartphone and web-based intervention for women with cardiac pain. BMJ Open. 2020 Mar 9;10(3):e033092. doi: 10.1136/bmjopen-2019-033092.

  PMID: 32156763 DERIVED

MeSH Terms

Conditions

Pain; Coronary Artery Disease; Chronic Pain; Angina Pectoris

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain

Study Officials

• Monica Parry, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Parry, PhD

CONTACT

416.946-3561; monica.parry@utoronto.ca

Myra Leyden, MA

CONTACT

416.978.1327; myra.leyden@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It is not possible to blind the participants to group allocation due to the specific nature of the intervention; however, a data analyst at the University of Toronto's Faculty of Nursing who is blinded to treatment allocation will conduct the analysis ensuring neutrality of the outcome assessment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Coordinator, Nurse Practitioner Programs

Model Details: A two group parallel single blind pilot RCT.

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 11, 2019
• Study Start: August 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)